Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?

Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?

On December 5th 2017, semaglutide (Ozempic®), developed by Novo Nordisk, received its first global approval in the US.[1] Nine days later the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in the EU.[2] This was followed swiftly by Health Canada’s approval in January 2018.[3] [4] In all cases, semaglutide was approved for use in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control. The drug is dispensed as prefilled pens for subcutaneous injection once weekly. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.[3] It is administered on the same day each week, at any time and without regard for food intake.[1] Continue reading “Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?”

Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT

Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT

The recent first global approval of letermovir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT”

Durvalumab (IMFINZI®): Follow up Approval in Canada

Durvalumab (IMFINZI®): Follow up Approval in Canada

The recent first global approval[1] of durvalumab in the US has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[2], based on the development milestones tracked in AdisInsight.[3]

In November, 2017, durvalumab (Imfinzi™), developed by AstraZeneca via Medimmune, was also approved in Canada for the treatment of advanced bladder cancer (late stage and/or metastatic disease) as monotherapy in previously treated patients (second-line or greater).[4] Continue reading “Durvalumab (IMFINZI®): Follow up Approval in Canada”

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

The recent first global approval of glecaprevir/pibrentasvir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!”

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

AdisInsightThe recent first global approval of sarilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, sarilumab (Kevzara™), developed by Sanofi and Regeneron Pharmaceuticals, received its first global approval in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis”